The following data is part of a premarket notification filed by Abbott Spine, Inc. with the FDA for Nexlink Oct System, Model 7000 Series.
| Device ID | K090060 |
| 510k Number | K090060 |
| Device Name: | NEXLINK OCT SYSTEM, MODEL 7000 SERIES |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | ABBOTT SPINE, INC. 5301 RIATA PARK CT., BLDG F Austin, TX 78727 |
| Contact | David Padgett |
| Correspondent | David Padgett ABBOTT SPINE, INC. 5301 RIATA PARK CT., BLDG F Austin, TX 78727 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-09 |
| Decision Date | 2009-06-02 |
| Summary: | summary |